General Questions

TOPIC: General Questions about the trial

 Q1.      What is HeLP-GP measuring?

HeLP-GP will analyse patient variables (health literacy, e-health literacy, risk behaviour, health service use, BP, total cholesterol, HDL, LDL, quality of life) through patient surveys and clinical records.

Information on resource use associated with the intervention will be collected by research staff, including the cost of setting up the intervention: practice staff education, practice support visits and materials and web support.

The qualitative evaluation will provide feedback on the fidelity of the intervention, barriers to the adoption of the intervention and the experience of patients and providers with the intervention.

Q2.      Why is the study not providing GPs with a specific low literacy assessment tool?

Brief health literacy screening tools have been shown in research to lack sensitivity i.e they do not pick up patients with low health literacy

An assumption in the study is that there is a relationship between economic status and lower health literacy. Individual practices do not need to assess patients since the patient survey (which is a phone survey conducted by UNSW) incorporates instruments to measure both health literacy (HLQ) and ehealth literacy (eHEALS). We will be conducting the analysis according to results of these two instruments.

Q3.      Do the practice nurses have to be Registered Nurses (RNs) or can they be Enrolled Nurses (ENs)?

PNs participating in the study can be RNs or PNs as long as they are currently acting in the role of a practice nurse.

Q4.      Can more than one nurse do the training and participate?

Yes.

Q5. Can Aboriginal patients be involved in the study? Are there any considerations with the involvement of Aboriginal patients?

Aboriginal patients who are attending a mainstream practice can participate like any other patient provided they meet the eligibility criteria. The HeLP-GP study is not specifically targeting Aboriginal people for the study, and as such these patients are covered under the general requirements of the ethics approval for the study.

Q6. Is Cognitive behavioural therapy used in the intervention?

No, CBT is not part of the intervention. The HeLP-GP intervention will focus on teach-back by PNs and the Get Healthy Telephone counselling service utilising motivational interviewing techniques with goal setting.

Q7. What is the Socio-Economic Indexes for Areas (SEIFA) Score and how does it relate to me?

SEIFA is calculated by the Australian Bureau of Statistics (ABS). It contains several indicators including the one we are using which is a ranking of geographic areas according to their level of socio-economic advantage/disadvantage (the Index of Relative Socio-Economic Disadvantage (IRSD)). We are approaching practices located in Local Government Area (LGA) with a SEIFA score equal to or below the 6th decile.

Q8. Does the study have a privacy policy?

Issues of privacy and confidentiality related to the study are governed by the UNSW Code of Research conduct -  https://research.unsw.edu.au/unsw-research-code-conduct.

 It should also be noted that the project is funded by the National Health and Research Council which has strict guidelines for the management of research including privacy and confidentiality and the trial has been through a rigorous ethical process by the UNSW HREC which assessed the processes thoroughly in terms of the interaction with practices, patients and the management and collection of data.

Q9. What if not all of our GPs want to participate?

It is not a requirement of the study that all GPs/Nurses participate from a practice. The study will need to gain consent from the principal GP that we can conduct the study in the practice.

Q10. What if we can’t recruit 40 patients?

40 patients per practice is the best-case scenario. We understand that smaller practices may struggle with this – it is a target only.

Q11. If we are one of the first practices to sign up, how long will it be before the trial will start?

We cannot randomise practices until we have a good number of practices recruited. Therefore, there may be a period of delay. We can however keep you updated regarding the progress with recruitment and start some of the trial processes with your practice including data collection, installation of DCP and the de-identified audit.

Q12.  What is the eligibility and exclusion criteria for patients?

Eligible patients are those who are:

Aged 40-74 years

Overweight or obese (BMI≥28 recorded in last 12 months)

Speaking English and/or Arabic

With BP recorded in the clinical software within the previous 12 months

With access to a smart phone or tablet device

Exclusion criteria:

Please note: Some of the exclusion criteria will be determined by DCP. We will be asking the GP/PN to make a final eligibility assessment on the last five items via the printout the patient will receive from DCP

  • A diagnosis of Cardiovascular disease (includes angina, myocardial infarction, heart failure, heart valve disease (rheumatic or non-rheumatic), stroke (cerebrovascular accident))
  • A diagnosis of Diabetes requiring insulin or a current prescription for insulin
  • Taking medication for weight loss (Orlistat or Phenteremine)
  • A diagnosis of serious mental illness (includes schizophrenia, psychosis, bipolar depression and unipolar depression)
  • Experiencing recent weight loss (>5% in past 3 months)
  • Not speaking either English or Arabic at a competent level
  • Significant cognitive impairment
  • No access to a smartphone or tablet device
  • Physical impairment which prohibits engaging in moderate level physical activity

Q13.  Are patients with chronic disease on a GP management plan eligible to participate?

Yes provided their chronic disease is NOT Diabetes AND/OR Cardiovascular disease as these exclude patients from the trial (see Question 12).

Q14.Could the nurse perform the health check and the GP then see the patient for a brief consult and claim MBS?

Yes.

Q15. Has the study calculated how much of the nurses time is required for the study?

Yes. Approximately 44 hours over a 6-month period (based on recruitment of 40 patients). This is based on 40-minute health checks and 20 minute follow up visits; one hour of training and 2-3 hours of facilitation.

Q16. Why aren’t patients under 40 years of age being recruited for the study?

Guidelines (including the RACGP Red Book and NHMRC) indicate that around 40 years of age is the point at which intervention is indicated to prevent further chronic conditions, such as cardiovascular disease.

Q17. Does my practice have to have accreditation to participate in the study?

No, your practice does not need to have accreditation to participate in the study.

Q18. Do GPs get reports from the Get Healthy Service regarding the patient’s progress?

Yes, if the referrer (PN in this case) ticks the box on the referral form requesting feedback letters. These feedback letters are provided at baseline, mid-point and graduation.